fesoterodine fumarate

FDA Drug Profile — Toviaz, fesoterodine fumarate

Drug Details

Generic Name
fesoterodine fumarate
Brand Names
Toviaz, fesoterodine fumarate
Application Number
NDA022030
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
6
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
FESOTERODINE FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.'s TOVIAZ ® (fesoterodine fumarate) Extended-Release Tablets. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.